The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
研究概览
简要总结
To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients.
详细描述
Patients undergoing kidney transplant follow ups in our center are screened based on recruitment criteria. Patients who fulfilled the incusion criteria are recruited. Intervention involves a 20-minute mindful breathing session with uniform script performed by trained personal, while control arm involves standard care without intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult renal transplant patients aged 18 years and older
- •At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS)
排除标准
- •Dialysis-dependent
- •Medically unstable
- •Having serious pre-existing mental health issues
研究组 & 干预措施
Intervention Group
A 20-minute mindful breathing session guided by a trained medical doctor. The session consisted of four 5-minute breathing exercises done consecutively. Participants were instructed to close their eyes and bring their attention to their breathing, and re-direct their attention back to their breathing once they were distracted.
干预措施: 20-minute mindful breathing session (Other)
Control Group
No intervention was provided for control group.
结局指标
主要结局
Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
时间窗: 20 minutes
ESAS is a validated scale to assess 10 symptoms commonly experienced by patients, which are: pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, anorexia, other symptoms, and feelings of well-being. The severity of each symptom was rated on a numerical scale of 0 to 10 (0 = no symptom; 10 = worst possible symptom).
次要结局
- Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute(20 minutes)
- Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores(20 minutes)
研究者
A/Prof. Dr. Ng Kok Peng
Consultant Nephrologist
University of Malaya